A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area

NCT ID: NCT06221267

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-26

Study Completion Date

2024-06-30

Brief Summary

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This study is a single-arm, prospective, multicenter, observational registry study. It plans to enroll 120 migraine patients who meet the inclusion criteria and are treated with rimegepant in selected hospital outpatient clinics in the Greater Bay Area. The main purpose of this study is to observe the effectiveness of rimegepant in treating migraines in a real-world clinical setting, including the impact of rimegepant on the quality of life, functioning, productivity status of migraine patients, and patients' satisfaction with the use of rimegepant in treating migraines.

Detailed Description

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Conditions

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Migraine

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Rimegepant

No intervention. The study will record the usage, timing, frequency, and dosage of rimegepant in a real-world clinical setting.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants with headaches that meet the diagnostic criteria for migraines according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), with or without aura.
* Patients prescribed rimegepant by the attending physician for the treatment of migraines.
* Signed informed consent form.
* Age greater than 18 years.
* Not concurrently participating in other interventional clinical studies.

Exclusion Criteria

* Patients diagnosed with secondary headaches.
* Patients with severe visual, auditory, language, intellectual, memory, consciousness impairments or other conditions that prevent them from completing the questionnaire and follow-up.
* Pregnant or lactating female patients.
* Patients deemed by the investigator as unsuitable for participation in the study or unable to complete the 4-week follow-up.
* Patients with a known history of hypersensitivity reactions to rimegepant or its components.
* Evidence in the medical history suggesting the presence of uncontrolled or unstable cardiovascular diseases (such as ischemic heart disease, coronary artery vasospasm, or cerebrovascular ischemia), or a history of myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke, or transient ischemic attack within the past 6 months before the screening visit.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Sudan Peng, MD

Role: primary

86-20-81332621

Other Identifiers

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SYSKY-2023-1172-01

Identifier Type: -

Identifier Source: org_study_id

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